KR20150038189A - Method and system to manage diabetes using multiple risk indicators for a person with diabetes - Google Patents

Abstract

Methods and systems are described for informing a patient of a component associated with each daily risk range based on glucose measurements to help the patient identify whether leading the daily risk range of measured glucose values is hypoglycemia or hyperglycemia.

Description

[0001] METHOD AND SYSTEM FOR MANAGING DIABETES [0002] USING MULTIPLE RISK INDICATORS FOR A PERSON WITH DIABETES [

Diabetes mellitus is a chronic metabolic disturbance caused by the inability of the pancreas to produce sufficient amounts of hormones and metabolism to provide adequate absorption of sugars and carbohydrates. This dysfunction leads to hyperglycemia, i.e., an excess of analyte is present in the plasma. Persistent hyperglycemia has been associated with a variety of serious symptoms and life-threatening long-term complications such as dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic renal failure, retinal injury and limb amputation. Because healing is not yet possible, permanent therapy is needed to provide constant blood glucose control to keep the blood analyte level always within normal limits. Such blood glucose control is achieved by regularly feeding the external drug to the patient ' s body to reduce elevated levels of blood analytes.

External medications were often administered by daily multiple injection of a mixture of rapid and intermediate acting drugs via subcutaneous syringes. Although this treatment does not require frequent evaluation of blood analytes, the degree of blood glucose control achievable in this manner is found to be suboptimal because delivery is different from physiological drug generation, And into the bloodstream over a longer period of time. Improved blood glucose control may be achieved by administering once or twice daily injections of a long acting drug to provide a baseline drug and daily injections of an additional dose of the slow acting drug in an amount proportional to the amount of meal prior to each meal Can be achieved by so-called intensive drug therapy based on injection. Although traditional syringes have been at least partially replaced by drug pens, nonetheless, frequent injections are very uncomfortable for the patient, especially for those patients who can not reliably self-administer injections.

Significant improvements in the treatment of diabetes have been achieved by the development of drug delivery devices that eliminate the need for administration of a syringe or drug pen and a daily multiple dose in a patient. Drug delivery devices can be controlled to follow a standard or individually modified protocol to allow delivery of the drug in a manner that has greater similarity to naturally occurring physiological processes and to provide better blood glucose control to the patient have.

In addition, direct delivery into the intravenous or intraperitoneal space can be achieved by a drug delivery device. The drug delivery device may be configured as an implantable device for subcutaneous placement or may be configured as an external device having an infusion set for subcutaneous infusion into the patient via transdermal drug delivery, such as through a catheter, percutaneous insertion of a cannula, . The external drug delivery device may be mounted on a garment, hidden under or under the garment, mounted on the body, generally controlled via a user interface embedded in the device or to a separate remote device.

Drug delivery devices can be used to deliver a drug or a biologically active substance to a diabetic patient at a basal rate with an additional drug or "bolus" to treat a meal or high analyte value, level or concentration It was used to help manage diabetes. The drug delivery device is connected by a flexible hose to an injector, better known as an injection set. The injector typically has a subcutaneous cannula, an adhesive backed mount to which the cannula is attached. The cannula may include a quick disconnect to allow the cannula and mount to remain in place on the user's skin surface while the flexible tubing is disconnected from the injector. Regardless of the type of drug delivery device, blood analyte monitoring is required to achieve acceptable blood glucose control. For example, delivery of an appropriate amount of drug by a drug delivery device may be achieved by the patient often determining his or her blood analyte level and manually entering these values into the user interface for the external pump, It is necessary to calculate the appropriate modifications to the drug delivery protocol in use, i.e. dose and timing, and then communicate with the drug delivery device to adjust the operation of the drug delivery device accordingly. Determination of the blood analyte concentration is typically performed by an intermittent measuring device, such as a hand-held electronic meter, which receives the blood sample through an enzyme-based test strip and calculates the blood analyte value based on the enzyme reaction .

Recently, continuous analyte monitoring has also been used with drug delivery devices to enable better control of drug (s) injected into diabetic patients. In addition to glucose monitoring, people with diabetes often have to perform medications, such as insulin dosing. People with diabetes can self-administer insulin to reduce their blood glucose levels. There are a number of currently available mechanical devices that allow an individual to administer a predetermined amount of insulin, such as, for example, a hypodermic syringe, an insulin pen, and an insulin pump. One such insulin pump is Animas® Ping, a product manufactured by Animas Corporation. Another is Animas (R) Vibe, also manufactured by Nimas Corporation.

Persons with diabetes should maintain strict control over their lifestyle, for example, to avoid being adversely affected by irregular food intake or exercise. In addition, a physician treating a particular individual with diabetes may require detailed information about an individual's lifestyle to provide effective treatment or correction of treatment to control diabetes. Currently, one way to monitor the lifestyle of individuals with diabetes is to maintain an individual's paper logbook of their lifestyle. Another way is for individuals to rely on remembering facts about their lifestyle only and then pass these details to their doctor at each visit.

The aforementioned method of recording lifestyle information is inherently difficult, time consuming, and perhaps imprecise. The paper logbook is not always possessed by an individual, and may not be accurately created when necessary. Such a paper logbook is small, and therefore difficult to input detailed information that requires a detailed descriptor of lifestyle cases. Also, when asked by a physician who has to manually review and interpret information from a handwritten journal, an individual may often forget key facts about their lifestyle. There is no analysis provided by the paper logbook to refine or separate the constituent information. Also, there is no graphical summarization or summary of information. Entering data into an ancillary data storage system, such as a database or other electronic system, requires that information, including lifestyle data, be painstakingly written on these ancillary data stores. The difficulty of recording data encourages retrospective input of relevant information, which results in inaccurate and incomplete records.

Applicants have also found that if components inherent in this index, which also show the effect of hypoglycemia or hyperglycemia leading to a range of risk for a given risk index (i. E. The average daily risk range) Have been found to be further improved.

In one aspect, a system is provided for the management of diabetes of a subject. The system includes at least one glucose monitor, at least one biosensor, and a controller. The at least one glucose monitor is configured to measure glucose concentration based on an enzymatic reaction with a physiological fluid in at least one biosensor that provides an electrical signal indicative of glucose concentration. The controller communicates with at least one glucose monitor. The controller receives the glucose levels measured by the glucose monitor over a predetermined time period from at least one glucose monitor and the pump for a determination of an average daily risk range with a maximum hyperglycemic value and a maximum hypoglycemic value per day in a predetermined time period Wherein the maximum hyperglycemia and hypoglycemic values are also notified in combination with the daily daily range of risk of a predetermined time period.

In this aspect, the controller is configured to determine an average-daily-risk-range (ADRR) and a maximum hyperglycemia value and a maximum hypoglycemia value with the following equations and logic conditions:

LR = max ( RL ( BG ))

HR = max ( RH ( BG ))

The daily daily risk range is defined as DRR = LR + HR ,

Where the ADRR may include an average-daily-risk-range,

i can contain the number of days up to M days in order,

M may include the number of days for which the ADRR value is calculated,

LR may contain the maximum daily hypoglycemia,

HR may contain the highest daily hyperglycemia value,

If f ( BG ) < 0, then RL ( BG ) = R ( BG ); Otherwise, RL ( BG ) = 0 ,

If f ( BG ) > 0, RH ( BG ) = R ( BG ); Otherwise, RH ( BG ) = 0 ,

Where alpha = 1.084 (1.026 for mmol / L)

beta = 5.381 (1.861 for mmol / L)

γ = 1.509 (1.794 for mmol / L).

Also note that in this system, the controller is configured to notify the visual indication of maximum hyperglycemia and hypoglycemia values along with the daily daily range of risk of the average daily risk range. The number of glucose measurements for this system should be at least three times daily to determine the mean daily risk range and the maximum hyperglycemia and hypoglycemia values; The time period may comprise from about 1 day to about 120 days or any combination of these.

Another aspect is a method for managing diabetes of a user by at least a glucose monitor, a biosensor, and a controller. The method can be accomplished by the following steps: measuring a plurality of glucose values in a user's physiological fluid with a glucose monitor and a biosensor; Storing the measured glucose values in a memory of at least one of a monitor and a controller; Determining an average daily risk range from glucose values of a daily storing step of a predetermined time period; Calculating a maximum hyperglycemia value and a maximum hypoglycemia value from the stored glucose values every day in a predetermined time period; And notifying the daily mean daily risk range and maximum hyperglycemia and hypoglycemic values of the predetermined time period. In this method, the calculating step may comprise determining daily maximum hyperglycemia and hypoglycemia values with the following equations and logical conditions:

If f ( BG ) < 0, then RL ( BG ) = R ( BG ); Otherwise, RL ( BG ) = 0 ,

If f ( BG ) > 0, RH ( BG ) = R ( BG ); Otherwise, RH ( BG ) = 0 ,

LR = max ( RL ( BG ))

HR = max ( RH ( BG ))

LR may contain the maximum daily hypoglycemia,

HR may contain the highest daily hyperglycemia value,

The daily daily risk range is defined as DRR = LR + HR ,

Where alpha = 1.084 (1.026 for mmol / L)

beta = 5.381 (1.861 for mmol / L)

γ = 1.509 (1.794 for mmol / L).

Again, in this method, the step of determining the average daily risk range may include calculating the daily average by an equation of the form:

Where the ADRR may include an average-daily-risk-range,

i may contain the number of days up to M days in order,

M is the number of days.

In addition, in this method, the notification step may include displaying the maximum hyperglycemia and hypoglycemia values in one orthogonal graph, wherein one axis represents glucose values and the other axis represents days, and the daily daily risk range of the average daily range of risk And displaying on one orthogonal graph one axis representing a range of risk from low, medium and high and the other axis representing a number of days. The number of glucose measurements should be at least three times daily to determine the average daily risk range and maximum hyperglycemia and hypoglycemia values; It is noted that the predetermined time period may comprise from about 1 day to about 120 days or any combination of these.

These and other embodiments, features, and advantages will become apparent to those skilled in the art from a consideration of the following more detailed description of various exemplary embodiments of the invention in connection with the accompanying drawings, which are briefly described first.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate presently preferred embodiments of the invention and, together with the general description given above and the detailed description given below, serve to explain the features of the invention Wherein like reference numerals denote like elements).
1 illustrates an exemplary embodiment of a diabetes management system;
Figure 2 illustrates an example logic diagram of the technique used by the system of Figure 1;
Figure 3a illustrates the total daily risk range from glucose measurements taken at a predetermined time period, such as one day.
Figure 3b is a diagram illustrating the components of the daily hazard range of the glucose measurement of Figure 3a;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following detailed description should be understood with reference to the drawings, wherein like elements are denoted by the same reference numerals in different drawings. The drawings that are not necessarily drawn to scale illustrate selected embodiments and are not intended to limit the scope of the present invention. The detailed description exemplifies the principles of the invention by way of example and not limitation. This description will clearly make apparent to those skilled in the art the manufacture and use of the invention and describes some embodiments, adaptations, variations, alternatives and uses of the present invention, including what are presently considered to be the best modes of carrying out the invention.

As used herein, the term " about "or" roughly " for any numerical value or range is intended to encompass any suitable number of elements, Indicates dimensional tolerance. Also, as used herein, the terms "patient," "host," "user," and "subject" refer to any person or animal subject, While not intending to be limiting, the use of the invention for human patients represents a preferred embodiment. In addition, the term "user" also includes a nurse (e.g., a parent or guardian, nurse, or home care worker) as well as a patient using a drug infusion device. The term "drug" may include a drug or other chemical that causes a biological response in the user or patient's body.

1 illustrates a drug delivery system 100 in accordance with an exemplary embodiment. The drug delivery system 100 includes a drug delivery device 102 and a remote controller 104. The drug delivery device 102 is connected to the infusion set 106 via flexible tubing 108.

The drug delivery device 102 is configured to transmit data to and receive data from, for example, the remote controller 104 via the radio frequency communication 110. The drug delivery device 102 may also function as a stand-alone device with its own embedded controller. In one embodiment, the drug delivery device 102 is a drug infusion device and the remote controller 104 is a handheld portable controller. In such an embodiment, the data transmitted from the drug delivery device 102 to the remote controller 104 may include, but is not limited to, for example, drug delivery data, blood glucose information, baseline, bolus, insulin to carbohydrate ratio, And may include information such as an insulin sensitivity factor. The controller 104 may be configured to receive continuous analyte readings from a continuous analyte ("CGM") sensor 112. The data transmitted from the remote controller 104 to the drug delivery device 102 may be transmitted to the drug delivery device 102 via the drug delivery device 102 to allow the drug delivery device 102 to calculate the amount of drug to be delivered by the drug delivery device 102, . &Lt; / RTI &gt; Alternatively, the remote controller 104 may perform medication or bolus calculations and may send the results of such calculations to a drug delivery device. In an alternative embodiment, an intermittent blood analyzer 114 may be used alone or in conjunction with the CGM sensor 112 to provide data to either or both of the controller 102 and the drug delivery device 102 have. Alternatively, the remote controller 104 may include an integrated device integrated with the meter 114 (a); Or (b) two removable devices that can be docked together to form an integrated device. Each of the devices 102, 104, and 114 has a suitable micro-controller (not shown for brevity) that is programmed to perform various functions. For example, the microcontroller may be in the form of a mixed signal microprocessor (MSP) for each device 102, 104, or 114. Such MSPs may be, for example, Texas Instruments MSP 430 days, as described in patent application publication numbers US2010-0332445 and US2008-0312512, which are incorporated herein by reference in their entirety and are appended to the appendices of the present application. have. Each MSP 430 of these devices or an existing microprocessor may also be configured to perform the methods described and illustrated herein.

Measurement of glucose can be based on the physical conversion of glucose (ie, selective oxidation) by the enzyme glucose oxidase (GO). For example, in a strip type biosensor, the reactions that may occur in such a biosensor are summarized below in Equations 1 and 2.

[Equation 1]

Glucose + GO _(ox) → gluconic acid + GO _(red)

&Quot; (2) &quot;

GO _(red) + 2 Fe (CN) ₆ ^3- GO _(ox) + 2 Fe (CN) ₆ ^4-

As illustrated in Equation 1, glucose is oxidized to gluconic acid by the oxidized form of glucose oxidase (GO _(ox) ). It should be noted that GO _(ox) may also be referred to as "oxidized enzyme &quot;. During the chemical reaction of Equation 1, the oxidized enzyme GO _(ox) is converted to its reduced state represented by GO _(red) (i.e., the "reduced enzyme"). Next, the reduced enzyme GO _(red) is re-oxidized to GO _(ox) by reaction with Fe (CN) ₆ ^3- (referred to as oxidized mediator or ferricyanide) as illustrated in Equation 2 . Reduction of GO _(red) to its oxidized state GO _(ox) reduces Fe (CN) ₆ ^3- to Fe (CN) ₆ ^4- (referred to as reduced medium or ferrocyanide) do.

When the reactions described above are performed by an inspection voltage applied between two electrodes, an inspection current can be generated by electrochemical re-oxidation of the reduced medium at the electrode surface. Thus, in an ideal environment, the amount of ferrocyanide produced during the aforementioned chemical reaction is directly proportional to the amount of glucose in the sample located between the electrodes, so that the resulting inspection current will be proportional to the glucose content of the sample. Mediators such as ferricyanide are compounds that accept electrons from enzymes such as glucose oxidase and then donate electrons to the electrodes. As the concentration of glucose in the sample increases, the amount of reduced mediator formed also increases; There is therefore a direct relationship between the glucose concentration and the test current resulting from the reoxidation of the reduced medium. In particular, the movement of electrons across the electrical interface causes the flow of the test current (2 moles of electrons per mole of glucose to be oxidized). Therefore, the inspection current due to the introduction of glucose can be referred to as glucose current.

The analyte level or concentration may also be determined by use of the CGM sensor 112. The CGM sensor 112 includes a current sensing electrochemical sensor (not shown) for measuring the analyte with three electrodes operatively connected to the sensor electronics and covered by a clip and a biointerface membrane, Technology. The upper end of the electrode is in contact with an electrolyte phase (not shown), which may include a free-flowing fluid phase disposed between the sensing membrane and the electrode. The sensing membrane may comprise an enzyme that covers the electrolyte phase, such as an analyte oxidase. In this exemplary sensor, a counter electrode is provided for balancing the current produced by the chemical species being measured at the working electrode. In the case of analyte oxidase-based glucose sensors, the species measured at the working electrode is H ₂ O ₂ . The current produced by the working electrode (and flowing through the circuit to the counter electrode) is proportional to the diffusion flux of H ₂ O ₂ . Thus, a raw signal representing the concentration of blood glucose in the user's body can be generated, and thus can be used to estimate a significant blood glucose value. Details of the sensor and related components are shown and described in U.S. Patent No. 7,276,029, the disclosure of which is incorporated herein by reference as if fully set forth herein throughout this application. In one embodiment, continuous analyte sensors from the Dexcom Seven System (manufactured by Dexcom Inc.) can also be used in the exemplary embodiments described herein have.

The drug delivery device 102 may also be configured for two-way wireless communication with, for example, a remote health monitoring station 116 via a wireless communication network 118. The remote controller 104 and the remote monitoring station 116 may be configured for bi-directional wired communication, for example, over a telephone land-based communication network. The remote monitoring station 116 may be used, for example, to download upgraded software to the drug delivery device 102 and to process information from the drug delivery device 102. Examples of the remote monitoring station 116 may include, but are not limited to, a personal or networked computer, a personal digital assistant, another cellular telephone, a hospital based monitoring station, or a dedicated remote clinical monitoring station.

Drug delivery device 102 includes a central processing unit and processing electronics including memory elements for storing control programs and operational data, communication signals (i. E., Messages) to / from a remote controller 104 A display for providing operating information to the user, a plurality of navigation buttons for the user to input information, a battery for providing power to the system, an alarm for providing feedback to the user (e.g., (E.g., visual, auditory, or tactile), a vibrator to provide feedback to the user, a drug delivery mechanism for pressurizing the drug into the user's body through a side port connected to the infusion set 106 from a drug reservoir , Drug pump, and drive mechanism).

The components of the system described with reference to Figure 1 help people with diabetes manage their disease. However, to achieve the efficacy of managing the disease, people with diabetes will need more than these components. As the Applicant has recognized, the component or system should be able to provide easy-to-understand information that aids in the decision making of the person. To help with this, an index called the average daily risk range (ADRR) index was developed by Boris Kovatchev of the University of Virginia ( http://care.diabetesjournals.org/content/29/11/2433.full .pdf ; a copy of which is attached to the appendix to this application), which is incorporated herein by reference in its entirety. US Ser. No. 20090171589A1, the disclosure of which is incorporated herein by reference in its entirety as if fully set forth herein for ADRR, METHOD, SYSTEM AND COMPUTER PROGRAM PRODUCT FOR EVALUATION OF BLOOD GLUCOSE VARIABILITY IN DIABETES FROM SELF-MONITORING DATA FOR EVALUATING GLUCOSE VARIABILITY; Inventor: Boris P. It is provided by Kovachev. The ADRR index is designed to provide a "risk index" for people with diabetes who explain the overall risk that a person with diabetes has for adverse events due to glucose control. For example, a patient may be given an ADRR index of "23" in their daily report on their meter, pump or controller. Although these numbers are associated with moderate risk, how these numbers are associated with the patient's high glucose concentration and low glucose concentration (both of which can contribute to risk) and when the patient has high and low values It is unclear whether they can improve their blood glucose during a week that includes both having both.

Although the ADRR index provides simple numbers and categories, it may be difficult for doctors and patients to understand the statistics and what contributes to their value. The present invention transforms the input component of the ADRR to provide a clearer understanding of the nature of the ADRR index and how it is affected by the patient's blood glucose ("BG"). At this point, it is worth discussing how the ADRR index is determined. In particular, the glucose risk function defines a way to focus on the risk of each read R (BG) of the day. In one example, the daily risk range is determined as follows:

&Quot; (3) &quot;

내지

의 간격으로 변환시키기 위해 제공되며, 이때 112.5에서 0이다.Equation 3 is the scale function f of the blood glucose readings value and is an interval ranging from 20 to 600

To

, Where 0 is at 112.5.

&Quot; (4) &quot;

이면,

이고, 그렇지 않으면,

이다. 이러한 관계는

혈중 포도당 판독치와 관련된 저(low) 위험 값을 나타내며, 여기서

이다. 즉, 함수 f가 0 미만이면, RL _i 는 방정식 4와 동일하게 설정되고, 그렇지 않으면, RL _i 는 0과 동일하게 설정된다. 반면에,

이면,

이고, 그렇지 않으면,

이다. 이러한 관계는

혈중 포도당 판독치와 관련된 고(high) 위험 값을 나타내며, 여기서

이다. 즉, 함수 f가 0 이상이면, RH _i 는 방정식 4와 대략 동일하게 설정되고, 그렇지 않으면, RH _i 는 0과 동일하게 설정된다.Equation 4 is the risk value associated with blood glucose readings.

If so,

, Otherwise,

to be. This relationship

Represents a low risk value associated with blood glucose readings, where

to be. That is, if the function f is less than 0, then RL _i is set equal to Equation 4, otherwise RL _i is set equal to zero. On the other hand,

If so,

, Otherwise,

to be. This relationship

Represents a high risk value associated with blood glucose readings, where

to be. That is, if the function f is 0 or more, RH _i is set to be approximately equal to Equation 4, otherwise RH _i is set equal to zero.

로 정의되며, 이는 일자

에 속하는 모든

판독치 중 최대

값이다. 반면에, 소정 일자의 고혈당 값의 최대 값이

로 정의되며, 이는 일자

에 속하는 모든

판독치 중 최대

값이다. 판독치가 양의 f(BG) 값을 가졌으면, 위험은 고 혈중 포도당 RH로부터의 것이고, 판독치가 음의 f(BG) 값을 가졌으면, 위험은 저 혈중 포도당 RL로부터의 것이다. 그 결과, ADRR은 일일 위험 범위를 적어도 3개의 혈중 포도당 판독치가 존재하는 매일의 Max(RH)와 Max(RL)의 합으로 정의한다.The maximum value of the hypoglycemic value for a given day is

Is defined as the date

All of

Maximum of readings

Value. On the other hand, if the maximum value of the high blood sugar value

Is defined as the date

All of

Maximum of readings

Value. If the reading has a positive f (BG) value, the risk is from the high blood glucose RH, and if the reading has a negative f (BG) value, the risk is from the low blood glucose RL. As a result, the ADRR defines the daily risk range as the sum of Max (RH) and Max (RL) daily, where at least three blood glucose readings are present.

Equations 3 and 4 are used to determine the average of such daily risk ranges over a predetermined time period (e.g., M days), where? = 1.084 (1.026 for mmol / L); β = 5.381 (1.861 for mmol / L) and γ = 1.509 (1.794 for mmol / L). Then, the following operation can be performed:

&Quot; (5) &quot;

f(BG)²이라 하고, R ( BG ) = 10

f ( BG ) ² ,

&Quot; (6) &quot;

If f ( BG ) < 0, then RL ( BG ) = R ( BG ); Otherwise, RL ( BG ) = 0 ,

&Quot; (7) &quot;

If f ( BG ) > 0 , RH ( BG ) = R ( BG ); Otherwise, RH ( BG ) = 0 ,

&Quot; (8) &quot;

Where the daily maximum hypoglycemic value LR = Max (RL (BG)),

&Quot; (9) &quot;

Here, the maximum daily hyperglycemia value HR = Max (RH (BG)),

&Quot; (10) &quot;

The daily daily risk range is defined as DRR ⁱ = LR ⁱ + HR ⁱ ,

&Quot; (11) &quot;

From this

Where M is the number of days the DRR value is calculated,

In other words, there are three or more BG values.

Referring to FIG. 2, a logical diagram of the technique 200 used by the Applicant is illustrated. In step 202, blood glucose measurements are made by the patient using a glucose monitor and a biosensor (e.g., SMBG or CGM). This measurement is made through the physical conversion of glucose into the enzyme product in the physiological sample, and the measurement is stored in step 204. The patient may measure his or her glucose at step 206 after a short period of time, at which time the logic returns to step 202. [ Assuming that the patient has measured glucose several times a day over several days, the data may be used for analysis or may be uploaded to the server for analysis at step 208. In step 210, the logic finds the number of daily blood glucose measurements "N ". If N is greater than or equal to 3 (i.e., at least three measurements per day), the logic moves from step 212 to step 214, where the maximum value of the risk from the high glucose measurement (i.e. Max (RH) The calculation of the maximum risk (ie, Max (RL)) and total risk from glucose measurements is done daily in the form of a daily-risk-range (ie, DRR) from glucose measurements. In step 216, the logic determines a "D" number of days with a daily measurement of at least three glucose measurements. The logic determines in step 218 whether the total number of days is at least 14 days. If false, the logic returns at step 220 a message that insufficient data has been provided for the determination of the ADRR. If true in step 218, the logic queries whether the daily risk range DRR has been previously calculated. If true, the logic floats FIGS. 3A and 3B to notify at least one of ADRR, DRR, Max (RH) and Max (RL), otherwise, if false at step 222, Is omitted. The logic returns to step 228 after the step 224 or 226 with the main routine. As used herein, the terms "notify " or" notify "and variations of root terminology may include analytical sensors, drug infusion devices, or the like for a user, a caregiver (e.g., parent, guardian, nurse, A notification may be provided via a combination of text, voice, visual data, or all communication modes to a telecommunication device such as a cellular telephone, network server or remote monitoring system.

Referring to FIG. 3A, a notification of daily risk factors is shown (in the form of an average daily risk range ("ADRR")). In Figure 3b, the daily maximum hyperglycemic value RH1 of day n ... RHn and maximum hypoglycemia values RL1, RL2, RL3 ... A corresponding example of RLn is shown. The daily Max (RH) value is plotted as a positive value and displayed as a red bar extending over the line. The daily Max (RL) value is plotted as a negative value and is displayed as a blue bar extending down the line. Maximum hyperglycemia and hypoglycemia values Max (RH) and Max (RL) have an understanding of where a person with diabetes can improve the control of blood glucose without focusing specifically on one of the glucose measurements It is used to help.

Icons or symbols such as colored circles of suitable colors or combinations of colors and icons may be used, for example, to provide convenient markers of the Max (RH) and Max (RL) values described above. The center of Max (RH) can be displayed as a circle (or polygon) of one color, and the center of Max (RL) can be displayed as a circle (or polygon) of another color. The two circles have a fixed radius, and the fixed radius can serve as an additional marker of low and high risk. An alternative technique would still be to center the circle at the center of the Max (RH) and Max (RL) values, but resize them according to the values of Max (RH) and Max (RL).

In this alternative solution, the area of the circle can be configured to change linearly with the risk. A minimum circle radius corresponding to a circle drawn at risk of zero is defined, and a maximum circle radius corresponding to a circle drawn at risk of 100 is defined. The radius of the circle can be calculated using the radius = SQRT ((maximum radius ² - minimum radius ² ) * (hazard / 100) + minimum radius ² ). This will ensure that the area of the circle drawn changes precisely according to the daily risk.

Referring again to Figure 3a, the ADRR for this particular patient is indicated by an indicator of bracketing the range DRR index (referred to herein as "ADRR" and each lead) Throughout the reporting period of May 27 to May 27, the patient shows an "average" daily risk range considered high. The daily risk range DRR is shown daily from April 30 to May 27. While an average or daily risk range DRR provides a good indication to the patient that his or her glycemic control may not be optimal, it may not provide a more useful indicator of the ingredient that starts to increase the daily risk to the patient. For example, low glucose values are considered to be more dangerous than high glucose values, and days with both low and high glucose values are considered to be more dangerous than days with only low or high glucose values.

By providing an understanding of the components (maximal hypoglycemia and maximal hyperglycemia) leading to a range of risk (e.g., ADRR or DRR) in the form of Figure 3b in conjunction with ADRR and DRR, Applicants have shown to the patient the danger zone, May provide a deeper understanding of whether low or high glucose levels are elevated or maintained high. Several examples will be discussed with respect to FIGS. 3A and 3B to demonstrate the applicant's advantages.

In Figure 3a, for example, the May 3 DRR shows a very high risk. However, the patient can not determine whether these high risks are caused by very high blood glucose, by very low blood glucose, or by both high blood glucose and low blood glucose values. Looking back to our Applicant's invention (as implemented in FIG. 3b), the maximum hyperglycemia Max (RH5 / 3) was higher on this day with a lower maximal hypoglycemia Max (RL5 / 3) It is evident that it contributes to the high risk represented in the DRR of the work.

In another example, labeled as May 15 in Figure 3A, the DRR of this day is also very high, but without the Applicant &apos; s invention, the patient will have a high blood glucose level or low blood glucose level, It can not be judged whether or not it contributes to. However, by the notification in FIG. 3b, it can be seen that virtually all the risks are attributable to the maximal hyperglycemia Max (RH5 / 15). The maximum value Max (RH5 / 15) indicates that virtually all risks on this day were due to high blood glucose measured on May 15.

On the other hand, on May 17, the DRR of the patient of FIG. 3a shows a high level of risk, which, without FIG. 3b, provides a necessary understanding of what constitutes a high glucose value or a low glucose value To the patient. Looking back to FIG. 3b, it can be seen that most of the risk was due to low glucose values measured during May 17.

While the present invention has been described with reference to specific variations and illustrative figures, those skilled in the art will recognize that the invention is not limited to the described variations or drawings. In addition, those skilled in the art will recognize that the order of certain steps may be altered, and such changes will be in accordance with the modifications of the invention, provided that the above-described methods and steps illustrate certain instances in which the order of occurrences occurs. Also, the predetermined steps may be performed concurrently, if possible, in parallel, and may also be performed sequentially, as described above. Accordingly, wherever there are variations of the invention that are within the scope of the present disclosure or equivalent to the present invention as identified in the claims, the present patent is also intended to include such modifications.

Claims (11)

As a system for the management of diabetes of a subject,
At least one glucose monitor configured to measure the glucose concentration based on an enzymatic reaction with a physiological fluid in a biosensor providing an electrical signal indicative of glucose concentration; And
CLAIMS What is claimed is: 1. A controller for communicating with at least one glucose monitor, comprising: means for determining an average daily risk range with a maximum hyperglycemic value and a maximum hypoglycemic value per day in a predetermined time period, And a controller configured to receive or transmit glucose levels measured by the glucose monitor over the predetermined period of time from the pump,
Wherein the maximum hyperglycemia and hypoglycemic values are also combined in combination with the daily risk range of each day of the predetermined time period. 2. The method of claim 1, wherein the controller is configured to determine the mean-daily-risk-range (ADRR) and the maximum hyperglycemia value and the maximum hypoglycemia value with the following equations and logic conditions: System for:

LR = max ( RL ( BG ))
HR = max ( RH ( BG ))
The daily daily risk range is defined as DRR = LR + HR ,
Wherein the ADRR includes the average-daily-risk-range,
i contains the number of days up to M days in order,
M includes the number of days for which the ADRR value is calculated,
LR contains the daily maximum hypoglycemia,
HR contains the above-mentioned maximum hyperglycemia value,

If f ( BG ) < 0, then RL ( BG ) = R ( BG ); Otherwise, RL ( BG ) = 0 ,
If f ( BG ) &gt; 0, RH ( BG ) = R ( BG ); Otherwise, RH ( BG ) = 0 ,
Where alpha = 1.084 (1.026 for mmol / L)
beta = 5.381 (1.861 for mmol / L)
γ = 1.509 (1.794 for mmol / L). 3. The system of claim 2, wherein the controller is configured to notify, on a visual display, the maximum hyperglycemia and hypoglycemia values in combination with the daily risk range of each day of the average daily risk range, . 4. The system of claim 3, wherein the number of glucose measurements should be at least three times daily for determination of the average daily risk range and the maximum hyperglycemia and hypoglycemic values. 5. The system of claim 4, wherein the time period comprises from about 1 day to about 120 days or any combination of these. A method for managing diabetes of a user by at least a glucose monitor, a biosensor and a controller,
Measuring a plurality of glucose values in a user's physiological fluid with the glucose monitor and the biosensor;
Storing the measured glucose values in a memory of at least one of the monitor and the controller;
Determining an average daily risk range from the glucose values of the storing step on a daily basis of a predetermined time period;
Calculating a maximum hyperglycemia value and a maximum hypoglycemia value from the stored glucose values each day of the predetermined time period; And
And reporting said average daily risk range and said maximum hyperglycemia and hypoglycemic values on a daily basis of said predetermined time period. 7. The method of claim 6, wherein said calculating step comprises ascertaining said maximum hyperglycemia and hypoglycemia values daily with the following equations and logical conditions:

If f ( BG ) < 0, then RL ( BG ) = R ( BG ); Otherwise, RL ( BG ) = 0 ,
If f ( BG ) &gt; 0, RH ( BG ) = R ( BG ); Otherwise, RH ( BG ) = 0 ,
LR = max ( RL ( BG ))
HR = max ( RH ( BG ))
LR contains the daily maximum hypoglycemia,
HR contains the above-mentioned maximum hyperglycemia value,
The daily daily risk range is defined as DRR = LR + HR ,
Where alpha = 1.084 (1.026 for mmol / L)
beta = 5.381 (1.861 for mmol / L)
γ = 1.509 (1.794 for mmol / L). 8. The method of claim 7, wherein the determining step of the average daily risk range comprises calculating the average daily with an equation of the form:

Wherein the ADRR comprises the average-daily-risk-range,
i contains the number of days up to M days in order,
M is the number of days. 9. The method of claim 8, wherein the notifying step comprises: displaying the maximum hyperglycemia and hypoglycemia values in one orthogonal graph wherein one axis represents glucose values and the other axis represents days, The method of claim 1, wherein the daily risk range comprises displaying on a different orthogonal graph where one axis represents a range of risks from low, medium, high and the other axis represents days, A method for the management of. 4. The method of claim 3, wherein the number of glucose measurements should be at least three times daily to determine the average daily risk range and the maximum hyperglycemia and hypoglycemic values. 9. The method of claim 8, wherein the predetermined time period comprises from about 1 day to about 120 days or any combination thereof.

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